Fatty Liver and Pancreatic Steatosis

NCT06757348 | Not Yet Recruiting

• 1 other identifier: HCJSM-11-2024
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine the prevalence of pancreatic steatosis in patients with fatty liver and determine the prevalence of exocrine pancreatic insufficiency (EPI) in these patients. Participants with fatty liver and metabolic syndrome will undergo fecal elastase measurement and endoscopic ultrasound (EUS).

Conditions

Exocrine Pancreatic Insufficiency; Fatty Liver, Nonalcoholic; Pancreatic Steatosis

Keywords

Fatty liver; Pancreatic steatosis; Metabolic syndrome

Outcome Measures

Primary Outcomes (3)

• Prevalence Non-Alcoholic Fatty Pancreas Disease

  Determine the prevalence of Non-Alcoholic Fatty Pancreas Disease (NAFPD) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

  At baseline

• Prevalence of exocrine pancreatic insufficiency

  Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Non-Alcoholic Fatty Pancreas Disease (NAFPD).

  At baseline

• Prevalence of IPE in MAFLD

  Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

  At baseline

Secondary Outcomes (2)

• Clinical characteristics

  At baseline

• Cytokine profile

  At baseline

Interventions

Fecal elastase DIAGNOSTIC_TEST

\*\*Stool Samples\*\* To investigate exocrine pancreatic insufficiency (EPI), a stool sample will be requested from all patients for fecal elastase (Fel-1) analysis. Participants will be instructed to collect their stool sample in a sterile, disposable plastic container and submit it to the Gastroenterology Chemistry Laboratory (Litwin Laboratory) for processing and analysis. Based on previously published reports, samples will be stored refrigerated at 4-8 °C for no more than 48 hours. The concentrations of Fel-1 in all samples will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (ScheBo-Pancreatic Elastase 1™, Giessen, Germany), and fecal elastase will be extracted and analyzed according to the manufacturer's instructions.

Ecoendoscopy DIAGNOSTIC_TEST

\*\*Diagnosis of Pancreatic Steatosis\*\* The diagnosis of pancreatic steatosis will be performed using endoscopic ultrasound. A Pentax EG-3870UTK endoscope will be used in conjunction with Hitachi Avius ultrasound equipment. The procedure is performed under anesthesia using propofol.

Fibroscan DIAGNOSTIC_TEST

\*\*Fibroscan Procedure:\*\* This is a new technique based on the evaluation of liver elasticity or stiffness that allows for the measurement of liver hardness and quantification of liver fibrosis in a simple and completely painless manner using ultrasound. The results are obtained immediately and can be safely repeated periodically.

Serum cytokines DIAGNOSTIC_TEST

Peripheral blood will be drawn from all participants in the Gastroenterology Division of the Hospital de Clínicas. Samples will be collected in EDTA tubes, centrifuged, and the serum will be frozen at -80 °C until processing. Serum cytokine levels will be measured using a commercial kit (Bio-Plex Pro human cytokine, Bio-Rad Lab., Inc.), which includes a panel of 27 cytokines: FGF basic, Eotaxin, G-CSF, GM-CSF, IFN-γ, IL-1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, MIP-1α, IL-12 (p70), MIP-1β, IL-13, PDGF-BB, IL-15, RANTES, IL-17, TNF-α, IP-10, VEGF, MCP-1 (MCAF).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

You may qualify if:

• Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

You may not qualify if:

• \- Alcohol consumption \>20 g/day in women, \>30 g/day in men
• Chronic hepatitis B or C infection
• Autoimmune liver diseases: autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
• Hereditary hemochromatosis
• Wilson's disease
• Alpha-1 antitrypsin deficiency
• Celiac disease
• Uncontrolled thyroid disease
• Active or chronic infectious disease
• Active cancer or ongoing treatment
• Chronic renal insufficiency
• Pregnancy/lactation
• Insufficient data
• Patients who do not complete follow-up

Sponsors & Collaborators

• Maria Marta Piskorz: lead

Study Sites (1)

Hospital de Clinicas Jose de San Martin

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1119, Argentina

Location

Related Publications (7)

• Olmos JI, Piskorz MM, Litwin N, Schaab S, Tevez A, Bravo-Velez G, Uehara T, Hashimoto H, Rey E, Sorda JA, Olmos JA. Exocrine Pancreatic Insufficiency is Undiagnosed in Some Patients with Diarrhea-Predominant Irritable Bowel Syndrome Using the Rome IV Criteria. Dig Dis Sci. 2022 Dec;67(12):5666-5675. doi: 10.1007/s10620-022-07568-8. Epub 2022 Jun 15.

  PMID: 35704255 RESULT

• Bellentani S. The epidemiology of non-alcoholic fatty liver disease. Liver Int. 2017 Jan;37 Suppl 1:81-84. doi: 10.1111/liv.13299.

  PMID: 28052624 RESULT

• Bedogni G, Miglioli L, Masutti F, Castiglione A, Croce LS, Tiribelli C, Bellentani S. Incidence and natural course of fatty liver in the general population: the Dionysos study. Hepatology. 2007 Nov;46(5):1387-91. doi: 10.1002/hep.21827.

  PMID: 17685472 RESULT

• Weiss J, Rau M, Geier A. Non-alcoholic fatty liver disease: epidemiology, clinical course, investigation, and treatment. Dtsch Arztebl Int. 2014 Jun 27;111(26):447-52. doi: 10.3238/arztebl.2014.0447.

  PMID: 25019921 RESULT

• Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.

  PMID: 32044314 RESULT

• Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.

  PMID: 32278004 RESULT

• Dominguez-Munoz JE. Diagnosis and treatment of pancreatic exocrine insufficiency. Curr Opin Gastroenterol. 2018 Sep;34(5):349-354. doi: 10.1097/MOG.0000000000000459.

  PMID: 29889111 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and stool samples

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Non-alcoholic Fatty Liver Disease; Fatty Liver; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Liver Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

MARIA M PISKORZ, MD

CONTACT

+5491133192885; neurogastrohc@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: January 3, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

AR (1)